Prialt (Ziconotide) In Severe Chronic Pain
A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain
1 other identifier
interventional
220
1 country
44
Brief Summary
The purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with severe chronic pain. During the weaning phase, the study will also gather information about switching from other intrathecal or IT medication (slowly pumped directly into the space around the spine) to other systemic pain medication (by mouth or through the skin using a patch). After being weaned off current IT medication, patients will be placed on IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of systemic pain medications. Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pain
Started Aug 2002
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 16, 2002
CompletedFirst Posted
Study publicly available on registry
October 17, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedDecember 14, 2015
December 1, 2015
October 16, 2002
December 10, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patient is able to read, understand, and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document prior to the performance of any study-specific procedures;
- Patient must be male or female at least 18 years of age;
- Patient must have severe chronic pain for whom IT therapy is warranted;
- Patient must be willing and able to comply with the protocol, and able to maintain the Patient Daily Diary for Opioid Consumption;
- Patient must have an implanted programmable SynchroMed® Infusion System in place for the treatment of chronic pain;
- Female patients of childbearing age agree to use adequate, appropriate contraceptive methods.
- Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods.
You may not qualify if:
- Patient is pregnant or lactating;
- Patient has been on an investigational drug other than ziconotide or device within 30 days prior to the initiation of the study drug;
- Patients with a known hypersensitivity (allergy) to ziconotide or any of the excipients (other compounds) in the formulation;
- Patient has a condition that would contraindicate the use of IT analgesia, including the presence of infection at the microinfusion injection site (where the needle is inserted in your abdomen to fill the pump with medication), uncontrolled bleeding diathesis (tendency for bleeding) and spinal canal obstruction that impairs circulation of Cerebral Spinal Fluid.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Tennesee Valley Pain Consultants - Center For Pain Management
Huntsville, Alabama, 35801, United States
The Pain Center
Northport, Alabama, 35476, United States
Outcomes Research International
Tucson, Arizona, 85711, United States
The RC Goodman Pain Institute: Clinical Research
Fort Smith, Arkansas, 72901, United States
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, 71913, United States
Innovative Spine Care
Little Rock, Arkansas, 72205, United States
Advanced Pain Medicine
Bakersfield, California, 93311, United States
Advanced Pain Institute
Duarte, California, 91010, United States
UCSD Medical Center, Thornton Hospital
La Jolla, California, 92037, United States
Abaci and Massey Pain Center
Los Gatos, California, 95032, United States
UCSF Pain Management Center
San Francisco, California, 94143-1654, United States
Pain Care Specialists
Colorado Springs, Colorado, 80907, United States
Clinical Pharmacology Services, Inc.
Tampa, Florida, 33617, United States
Georgia Medical Research Institute
Marietta, Georgia, 30060, United States
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, 60612, United States
University of Kentucky, Dept Anesthesiology
Lexington, Kentucky, 40536, United States
Johns Hopkins Hospital, Division of Pain Management
Baltimore, Maryland, 21205, United States
Arnold Pain Management
Boston, Massachusetts, 02215, United States
Edina Medical Pain Center
Edina, Minnesota, 55435, United States
Research Medical Center - Pain Institute
Kansas City, Missouri, 64132, United States
Yellowstone Medical Center East
Billings, Montana, 59101, United States
Huntington Center for Pain Treatment
Huntington, New York, 11743, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Medical Pain Management of Central NY
Syracuse, New York, 13210, United States
Center For Clinical Research
Winston-Salem, North Carolina, 27103, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Pain Institute of Tulsa
Tulsa, Oklahoma, 74137, United States
Pain Consultants of Oregon
Eugene, Oregon, 97401, United States
Legacy Holladay Park Medical Center
Portland, Oregon, 97232, United States
Penn State University Hospital
Hershey, Pennsylvania, 17033, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Advanced Clinical Concepts
Temple, Pennsylvania, 19560, United States
Neurosurgery Foundation
Providence, Rhode Island, 02903, United States
MUSC, Neurological Surgery
Charleston, South Carolina, 29425, United States
Methodist Comprehensive Pain Institute
Memphis, Tennessee, 38104, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Tech University HSC
Lubbock, Texas, 79430, United States
Consultants in Pain Research
San Antonio, Texas, 78217, United States
Alpine Pain and Addiction Medicine
Salt Lake City, Utah, 84107, United States
Advanced Pain Management and Rehabilitation
Virginia Beach, Virginia, 23454, United States
University of Washington Medical Center - Pain Center
Seattle, Washington, 98195, United States
Center for Pain Relief
Charleston, West Virginia, 25301, United States
Cardinal Clinical Research Center
Cudahy, Wisconsin, 53110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2002
First Posted
October 17, 2002
Study Start
August 1, 2002
Study Completion
June 1, 2003
Last Updated
December 14, 2015
Record last verified: 2015-12